GMP Operational Quality Senior Specialist
GMP Operational Quality Senior Specialist
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Job Description
Job Description
General Summary:
The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives.
Key Duties and Responsibilities:
- Supports quality oversight for root-cause analysis and product impact assessment for investigations as a result of deviations OOS and OOT investigations ensuring appropriate CAPA actions are identified.
- Supports change control assessments implementation and closure
- Identifies and facilitates continuous improvement efforts
- Supports drafting and revising Quality Agreements between CMOs/Suppliers and Vertex as needed
- Helps represents Vertex Quality on cross-functional working teams applying strong communication and collaboration skills.
- Support continuous improvement projects
Knowledge and Skills:
- Experience supporting multiple projects/teams within stated objectives and timelines
- Experience supporting cross-functional team members and collaborate effectively
- Good communication skills (written and verbal) and the ability to exchange potentially complex information
- Able to integrates activities with other groups departments and project teams as needed
- Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent
- Ability to work in a fast-paced environment and meet quality accuracy and timeliness objectives
- Expanded conceptual knowledge of cGMPs in a pharmaceutical setting
- Proficient in leading event investigations Root Cause Analysis (RCA) and CAPA
Education and Experience:
- Bachelors degree in scientific or allied health field (or equivalent degree)
- Typically requires 2 years of experience or the equivalent combination of education and experience
#LI-onsite
Pay Range:
$92800 - $139200Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Director
Employment Type
Full-Time
